345314BR
May 25, 2022
India

Job Description

5! The number of projects you will be leading to develop our growing pipeline of Gene Therapy products. We are looking for an experienced professional in the area of drug product development for Gene Therapy-based drug products, with special focus on viral vectors. As a member of Pharmaceutical Development in the Cell and Gene Therapy Development Unit, Technical Development NBEs, you will play a key role in the development of parenteral dosage forms of viral and non-viral vectors, for gene therapy, for preclinical and clinical studies, as well as in the development of market formulations.

Job Purpose:

We are looking to hire a positive, proactive Project manager to oversee project teams and to ensure the projects are completed on time. In this role you will be accountable for the complete project management cycle of each and every iDOT project that the team takes up, ensuring that the quality of each application hosted on the iDOT platform. You’ll aslo lead the continuous improvement of the iDOT applications at a strategic level.
The role would also include extensive stakeholder engagement and management to ensure that all the concerned stakeholders (developers as well as the functional SPOCs) adhere to the proposed project plan, in terms of the timeline, budget and scope.

Your key responsibilities:
Your responsibilities include, but not limited to:

• Adept and working knowledge of different Project management models, creating project plan, Raci metrics, implementation of projects and regular tracking. Practical knowledge of risk identification and mitigation in project management. Liaising with the concerned stakeholders regarding project requirements.

• Contributing, outlining, defining, and initiating the project plan. Implementing document control policies and documentation templates. Flexible to work in different project roles as need arises. Maintaining a good working knowledge of assigned component projects.


• Working with the functional spocs for evaluating standards of component products. Monitoring project progress and working with the functional SPOCs and the development team to make changes to the project plan where necessary.

• Compiling project reports and informing management regarding problems. Ensuring project complies with best practices, SOPs, PMO policies, and other policies.

• Outstanding leadership, organizational, and time management skills. Outstanding verbal and written communication skills.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

Education: (Minimum/desirable):

M Tech/ ME/ MBA/ B-Tech/ BE/ BSc / MSc or equivalent degree in Computer Science, Electronics, Biotech, Statistics and other branches having experience in Information Technology and software development.
Fluent English (Oral and Written)


Experience/Professional requirement:

• 10-15 years experience in managing clinical application development and business analytics, gained in the pharmaceutical industry, CRO or Life Science related industry as well as the following.

• Thorough understanding of project management fundamentals. Understanding of agile software development life cycle models. Knowledge of clinical data management systems and/or relational databases (e.g. OC/RDC, INFORM, RAVE) as applied to clinical trials.

• Understanding of Drug Development Process, ICH-GCP, CDISC standards and Health Authority guidelines and regulations. Excellent verbal communication skills.

• Attention to detail, quality, time management and customer focus . Ability to work independently, in teams, under pressure, demonstrating initiative and flexibility through effective and innovative technical ability.

Desired skills:

• A bachelor's degree in IT, computer science, business management, or a related field. Any relevant project management related experience. A Project Management Professional (PMP) certification is preferred.

• Preference will be given to candidates having prior knowledge about Data Management, Statistical Programming, Database programming and Clinical Standards.

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
GDO GDD
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
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345314BR

Principal Process & Training Lead

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